Study Ties Antidepressants to Birth Defects

A study of nearly 28,000 women linked antidepressants Paxil and Prozac to a small increase in birth defects, but cleared three other antidepressants of such concerns.

The study, published in British Medical Journal, found five types of birth defects associated with Paxil (paroxetine) and two types associated with Prozac (fluoxetine) that occur more frequently among women treated with the drugs during early pregnancy.

The study examined five selective serotonin reuptake inhibitors, including Celexa (citalopram), Lexapro (escitalopram) and Zoloft (sertraline) along Paxil and Prozac, taken by 17,952 mothers of infants born with birth defects and 9,857 mothers of infants born without birth defects between 1997 and 2009. No association was found between Celexa, Lexapro and Zoloft and birth defects.

The authors — researchers from the U.S. Centers for Disease Control and Prevention, Boston University and the University of British Columbia — stressed that the increase in absolute risk was small for mothers who took Paxil and Prozac. For example, the increase in anencephaly, a brain and skull defect, for children whose mothers were treated with Paxil increased from 2 in 10,000 to 7 in 10,000 and the number of heart defects increased from 10 per 10,000 to 24 per 10,000.

“Additional studies of specific SSRI treatments during pregnancy are needed to enable women and their healthcare providers to make more informed decisions about treatment,” the authors say. They could not prove the drugs caused the defects.

Apotex, which holds the NDA for Paxil in the U.S., and Prozac owner Eli Lilly could not be reached for comment by press time.

Read the study here www.fdanews.com/07-13-15-britishstudy.pdf. — John Bechtel